Presentation is loading. Please wait.

Presentation is loading. Please wait.

The Global Health Network

Similar presentations


Presentation on theme: "The Global Health Network"— Presentation transcript:

1 The Global Health Network
Sourcing, Preparing and Accounting for Investigational Products Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014

2

3

4 IMP/IP IMP (Investigational Medicinal Product) /
IP (Investigational Product) Sourcing and Receipt Storage Dispensing/Blinding Randomisation Disposal/Destruction UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

5 IMP/IP IMP (Investigational Medicinal Product) /
IP (Investigational Product) Sourcing and Receipt Storage Dispensing/Blinding Randomisation Disposal/Destruction UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

6 Sourcing and Receipt Sponsor-driven Phase I:
New IMP & Formulation Sponsor arranges manufacture Importing Dummy Dispensing Investigator-led Phase III: Typically Locally-Marketed Product Pharmacist sources IMP Source of Accountability: Delivery waybills, Prescriptions, Invoices, Receipt Accountability UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

7 Sourcing and Receipt Sponsor-driven Phase I:
Receipt Accountability Sourcing and Receipt Sponsor-driven Phase I: New IMP & Formulation Sponsor arranges manufacture Importing Dummy Dispensing Investigator-led Phase III: Typically Locally-Marketed Product Pharmacist sources IMP Source of Accountability: Delivery waybills, Prescriptions, Invoices, Receipt Accountability

8 IMP/IP IMP (Investigational Medicinal Product) /
IP (Investigational Product) Sourcing and Receipt Storage Dispensing/Blinding Randomisation Disposal/Destruction UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

9 Storage Certificate of Analysis (COA)  light, temperature, humidity
Rigorous Control  E.g. fridges, air-con, probes, light protection Unique Storage Space Back-Up Plan Sources of Accountability: Temperature Logs, Calibration Certificates, SOPs, COAs UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

10 IMP/IP IMP (Investigational Medicinal Product) /
IP (Investigational Product) Sourcing and Receipt Storage Dispensing/Blinding Randomisation Disposal/Destruction These are components of accountability. Highlight differences btwn sponsor driven vs investigator led studies Investigator led: sourcing, accountability forms, manuals – derived from investigator and site. Sponsor: often provide documentation, IP in formulation, handling procedures, accountability forms and SOPs. Less required by site. UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

11 Dispensing Dispensing Licence Expiry Dates
IP prep (e.g. reconstitution, infusion) Labelling requirements  e.g. Participant ID, Study/Protocol/Investigator ID, Quantity Dispensed, Mode of Delivery, Storage Condition, Exp./Lot/Batch #’s Blinding – implication for dispensing directly to patient Unblinding procedure Dispensing licence required: hospital nurses have dispensing licence however relevant to their scope of practice within hospital, not clinical trials. GMP: anything more than reconstitution – refer to MCC webpage Blinding: double blinds vs single vs open label. Safe dispensing of blinding. Unblinding SOP – how to unblind when required. Example of closed envelopes per patient provided or can create yourself. As long as securely stored If intervention is vaccine/infusion and/or blinded study, implication for dispensing? Grey area re direct dispensing by pharmacist MCC documentation: SAPC registration, declaration, CV, Insurance (?) Source of accountability: MCC documentation, Pharmacy Manual (accountability, labels, patient dispensing logs) UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

12 Sourcing and Receipt Sponsor-driven Phase I:
Store Accountability Sourcing and Receipt Sponsor-driven Phase I: New IMP & Formulation Sponsor arranges manufacture Importing Dummy Dispensing Investigator-led Phase III: Typically Locally-Marketed Product Pharmacist sources IMP Source of Accountability: Delivery waybills, Prescriptions, Invoices, Receipt Accountability

13 IMP/IP IMP (Investigational Medicinal Product) /
IP (Investigational Product) Sourcing and Receipt Storage Dispensing/Blinding Randomisation Disposal/Destruction These are components of accountability. Highlight differences btwn sponsor driven vs investigator led studies Investigator led: sourcing, accountability forms, manuals – derived from investigator and site. Sponsor: often provide documentation, IP in formulation, handling procedures, accountability forms and SOPs. Less required by site. UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

14 Randomisation Treatment Allocation/Dispensing
Generated by statistician/pharmacist (sponsor or site produced), stored in secure location e.g. pharmacy file  Randomisation schedule or Automated system e.g. IVRS Randomisation log Source of accountability: Randomisation schedule and Randomisation logs UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

15 Sourcing and Receipt Sponsor-driven Phase I:
Randomisation Schedule Accountability Sourcing and Receipt Sponsor-driven Phase I: New IMP & Formulation Sponsor arranges manufacture Importing Dummy Dispensing Investigator-led Phase III: Typically Locally-Marketed Product Pharmacist sources IMP Source of Accountability: Delivery waybills, Prescriptions, Invoices, Receipt Accountability

16 Sourcing and Receipt Sponsor-driven Phase I:
Randomisation Log Accountability Sourcing and Receipt Randomization Log for: ACTIVE IMP Randomization Log for: PLACEBO FOR IMP Sponsor-driven Phase I: New IMP & Formulation Sponsor arranges manufacture Importing Dummy Dispensing Investigator-led Phase III: Typically Locally-Marketed Product Pharmacist sources IMP Focus on type of study e.g. blinded? – to assist with securing appropriate placebo to ensure blinding e.g. same smell, look, feel Focus on type of study e.g. blinded? Sponsor vs investigator-led Source of Accountability: Delivery waybills, Prescriptions, Invoices, Receipt Accountability

17 IMP/IP IMP (Investigational Medicinal Product) /
IP (Investigational Product) Sourcing and Receipt Storage Dispensing/Blinding Randomisation Disposal/Destruction These are components of accountability. Highlight differences btwn sponsor driven vs investigator led studies Investigator led: sourcing, accountability forms, manuals – derived from investigator and site. Sponsor: often provide documentation, IP in formulation, handling procedures, accountability forms and SOPs. Less required by site. UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

18 Return/disposal At conclusion of study, final inventory and reconciliation Sponsor-driven: return to sponsor for disposal or site arranges disposal Arrange with waste disposal company Source of accountability: Disposal/Destruction Log UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

19 Sourcing and Receipt Sponsor-driven Phase I:
Destruction Log Accountability Sourcing and Receipt Sponsor-driven Phase I: New IMP & Formulation Sponsor arranges manufacture Importing Dummy Dispensing Investigator-led Phase III: Typically Locally-Marketed Product Pharmacist sources IMP Source of Accountability: Delivery waybills, Prescriptions, Invoices, Receipt Accountability

20 SUMMARY Importance of pharmacy role: maintains accountability of IMP from start to finish, ensuring right dose given to right patient at the right time Accountability is a continuous process from start of study until closure Inform/involve pharmacy at the outset Resources available on CRC website - UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

21 SUMMARY Importance of pharmacy role: maintains accountability of IMP from start to finish, ensuring right dose given to right patient at the right time Accountability is a continuous process from start of study until closure Inform/involve pharmacy at the outset Resources available on CRC website -

22

23 | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014
4/15/2017 Questions? | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014 | UCT Clinical Research Centre | Pharmacy Core Group | 08 July 2014 | 1st Forum Meeting


Download ppt "The Global Health Network"

Similar presentations


Ads by Google